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RECRUITINGPhase 3INTERVENTIONAL

Phase III Trial of Stage I Ovarian Cancer After Surgery

Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with a diagnosis of histopathologically epithelial ovarian cancer 2. FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type) 3. Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy. 4. Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum (\[Peritoneal biopsy\] see details below), retroperitoneal lymph node dissection (see details below \[Retroperitoneal lymph node dissection\]). However, for the following cases, it is eligible as a condition to record on the official document. - Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed. - Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached. 5. Age: 20 or older 6. Performance status (PS):0-1 7. Case with initial therapy for postoperative primary lesion 8. Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery 9. Reasonable organ function 10. Patient must have signed willing to sign a consent form. Who Should NOT Join This Trial: 1. FIGO Stages Ic(a), Ic(1) and Ic(2) 2. Patients containing sarcoma elements 3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT 4. Patients with serious complications 5. Patients with active infection 6. Patients with intestinal paralysis or intestinal obstruction 7. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy 8. Patients with previous chemotherapy or radiation therapy ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients with a diagnosis of histopathologically epithelial ovarian cancer 2. FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type) 3. Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy. 4. Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum (\[Peritoneal biopsy\] see details below), retroperitoneal lymph node dissection (see details below \[Retroperitoneal lymph node dissection\]). However, for the following cases, it is eligible as a condition to record on the official document. * Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed. * Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached. 5. Age: 20 or older 6. Performance status (PS):0-1 7. Case with initial therapy for postoperative primary lesion 8. Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery 9. Reasonable organ function 10. Patient must have signed informed consent. Exclusion Criteria: 1. FIGO Stages Ic(a), Ic(1) and Ic(2) 2. Patients containing sarcoma elements 3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT 4. Patients with serious complications 5. Patients with active infection 6. Patients with intestinal paralysis or intestinal obstruction 7. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy 8. Patients with previous chemotherapy or radiation therapy 9. Patients with serious drug hypersensitivity 10. Patients with peripheral motor/sensory neuropathy \[grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0\] 11. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 12. Patients with positive HBsAg. Patients with more than 2.1 log/copies ml based on fixed Hepatitis B virus (HBV)-DNA who are positive with either antigen-positive Hepatitis B (HBs), anti-hepatitis B core antigen or anti-hepatitis B surface antigen. 13. Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

Treatments Being Tested

DRUG

adjuvant chemotherapy

combination of paclitaxel and carboplatin

Locations (20)

Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Tosei General Hospital
Seto-shi, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan
The Jikei University School of Medicine Kashiwa Hospital
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Ehime University Hospital
Onsen-gun, Ehime, Japan
Kyusyu Medical Center
Fukuoka, Fukuoka, Japan
Kyusyu Cancer Center
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
JA Hiroshima General Hospital
Hatsukaichi-shi, Hiroshima, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, Japan
Miyoshi Central Hospital
Miyoshi-shi, Hiroshima, Japan
Hospital Hakodate Hokkaido
Hakodate-shi, Hokkaido, Japan
JA Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan